DIANA-5: Randomized Trial to Test the Efficacy of Dietary Change and Physical Activity to Prevent or Delay the Development of Recurrences in Breast Cancer Patients Estimated to be at High Risk of Recurrence Hormonal and Metabolic Reasons
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,542
- 主要终点
- Reduction of recurrences
研究概览
简要总结
The investigators recruited 1542 Breast Cancer (BC) patients and to randomize the participants in two groups: 773 have received standard recommendations for healthy lifestyle without, however, any active support; 700 have received a combination of individual and group contacts over the course of one year, including kitchen courses, gym and dance classes, common meals and reinforcing meetings, with emphasis on a comprehensive dietary change including low saturated fat and low refined carbohydrates, and high whole grain cereals and pulses consumption. Compliance have been monitored through weight change and plasma glucose, triglycerides, cholesterol and testosterone.
The main analysis will be by intention to treat. Under the hypothesis of reducing recurrence rate by 25% or 33% the statistical power of the study is 80% or, respectively, 90%, (P<0.05, 5-year follow-up).
详细描述
Aims The investigators have been proposing a randomized intervention trial of diet and physical activity to reduce BC relapse (local, distant), and second ipsilateral or contralateral BC risk, in BC patients at high metabolic-endocrine of recurrence risk.
Secondary aims:
- to evaluate the effect of the combined dietary and physical activity change on the prevalence of Metabolic Syndrome
- to evaluate the effect of the combined dietary and physical activity change on the prevalence on risk biomarkers (BMI > 24.9 kg/m^2)
- to evaluate the effect of the combined dietary and physical activity change on the prevalence on risk biomarkers (testosterone >= 0.4 ng/ml)
- to evaluate the effect of the combined dietary and physical activity change on the prevalence on risk biomarkers (insulin > pmol/l)
- to evaluate the effect of the intervention on the development of other life-style related health conditions (other cancers, diabetes, hypertension, dyslipidemia, total mortality)
Recruitment:
Potential participants have been recruited at the time of diagnosis through follow-up clinics, patients' associations, or the media. Patients have been requested to sign an informed consent, including authorization for getting blood samples, for storing samples for future studies. The investigators collected demographic information, fasting measure body weight, height, waist circumference, and blood pressure, blood glucose, LDL and HDL cholesterol, triglycerides, testosterone and insulin. Eligible patients have filled in a baseline questionnaire on medical history, medication use, reproductive and body weight history, usual physical activity, and a validated semi-quantitative food frequency questionnaire.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Mastectomy or conservative surgery for invasive breast cancer, any type, in the last five years (the investigators recruited mostly patients at the time or after surgery, when chemotherapy has been concluded and hormonal therapy, if necessary, has been started)
- •Absence of signs or symptoms suggestive of recurrences
- •Presence of one or more of the following endocrine/metabolic indicators: serum testosterone level ≥ 0.4 ng/ml (1 nmol/ml), corresponding to the median value in BC patients, or serum insulin ≥ 50 pmol/L, corresponding to the upper quartile of insulin distribution in Breast Cancer patients, or metabolic syndrome, present in about 15% of Breast Cancer patients.
排除标准
- •Metastatic disease or previous relapse
- •Physical or mental handicaps that would have impeded to engage in moderate physical activity or participate in kitchen classes
结局指标
主要结局
Reduction of recurrences
时间窗: Baseline, fifth year
The investigators have been proposing a randomized intervention trial of diet and physical activity to change BC relapse (local, distant), and second ipsilateral or contralateral BC, in BC patients at high risk of recurrence because of biochemical markers of increased risk, namely high serum testosterone and/or high fasting insulin and/or metabolic syndrome. Several other markers of increased recurrence risk are available, such as cancer stage at diagnosis, histological grade, hormonal receptors and other gene expression profile. All these will be registered, but the investigators are specifically interested in markers of the host that can be modified through life-style.
次要结局
- Modification lifestyle and Insulin(Baseline, first year)
- Modification lifestyle and Metabolic Syndrome (MetS)(Baseline, first year)
- Development diabetes(Baseline, fifth year)
- Total mortality(Baseline, fifth year)
- Modification lifestyle and Body Mass Index (BMI)(Baseline, first year)
- Modification lifestyle and Testosterone(Baseline, first year)
- Development other cancer(Baseline, fifth year)
研究者
Anna Villarini
Biologist, Nutritionist, PhD and Senior researcher
Fondazione IRCCS Istituto Nazionale dei Tumori, Milano